Self-Administered Drug Exclusion List:

Background

The Social Security Act does not provide a comprehensive drug benefit for Medicare beneficiaries. For Part A (inpatient), drugs provided during acute inpatient stays and qualified skilled nursing facility stays are generally covered if Medicare requirements are met. For Part B (outpatient, including outpatient hospital such as the emergency room), drugs and biological coverage is generally limited to the type of drugs that cannot be self-administered (SA), are medically necessary and reasonable, are Food and Drug Administration (FDA) approved, and are incident to the services of physicians in the treatment of patients as defined in the Carrier, Intermediary and Hospital manuals. Payment for drugs and supplies used in the performance of procedures is included in the fee for the procedure and are not separately billable to Medicare or the beneficiary.

Congress changed the Medicare definition of the type of drugs that cannot be self-administered with passage of the Medicare, Medicaid, and State Children’s Health Insurance Program (SCHIP) Benefits Improvement and Protection Act (BIPA) of 2000 to usually not self-administered. As a result of this benefit structure, SA drugs and biologicals (pill form or injection form) in the outpatient setting are usually not covered except where Congress has provided for additional coverage. Examples of such coverage include specific blood clotting factors, drugs used in immunosuppressive therapy, renal dialysis related erythropoietin, osteoporosis drugs for certain homebound patients, some oral anti-cancer drugs, and some anti-nausea drugs in combination with oral or intravenous chemotherapy.

The Centers for Medicare and Medicaid Services (CMS) has published two Program Memorandums on this issue. Transmittal AB-02-072, Change Request 2200, which was released on May 15, 2002, provides clarification of Section 112 of the BIPA. Change Request 2200 supersedes the following program instructions:

- Medicare Carriers Manual, Section 2049.2
- Intermediary Manual, Sections 3112.4B & 3660.11
- Hospital Manual, Sections 230.4, E205 & 422.

This transmittal instructs contractors to define usually not self-administered as more than 50 percent of the time for all Medicare beneficiaries who use the drug. A drug self-administered by more than 50 percent of Medicare beneficiaries is excluded from coverage. This definition and other criteria in the transmittal will necessitate an evaluation process by Carriers and Intermediaries prior to applying the exclusion. Transmittal AB-02-139 Change Request 2311, which was released on 10/11/2002, provided additional guidance for applying the Medicare Self-Administered Drug Exclusion.

The Medicare exclusion is clear for oral drugs, suppositories and topical medications. For drugs that have previously been covered as an integral part of the procedure, (e.g., a topical ophthalmic anesthetic is not separately reimbursed but is considered part of the fee for the procedure), there is no change. The issues arise with the drugs that are given by intravenous (IV), intramuscular (IM), subcutaneous (SQ) or multiple routes of administration.

These transmittals instruct each individual contractor to develop a process for the determination on each drug. For drugs that have multiple indications and routes of administration, contractors will consider all of the indications and routes of administration when making a single determination for a drug.

Contractors must continue to apply the policy that not only is the drug medically reasonable and necessary for any individual claim, but also that the route of administration is medically reasonable and necessary. In making the determination, the contractor must use the guidelines in the transmittals, as well as to the extent available, any peer reviewed medical literature; standards of medical practice; FDA approval language, package inserts, other drug compendia as appropriate; evidence-based practice guidelines; and other information submitted by interested individuals or groups.

Terms Defined by the CMS

Acute Condition: a condition that is likely to be of short duration and/or the expected course of treatment is for a short, finite interval (usually less than 2 weeks).

Chronic Condition: a condition that is expected to last longer than 2 weeks.

Infrequent Use: less than once per week (e.g., once per month).

Frequent Use: once or more per week (e. g., once per week).

Administered: the term administered refers to the physical process by which the drug enters the patient’s body. It does not refer to whether the process is supervised by a medical professional (for example, to observe proper technique or side-effects of the drug). Only injectable (including intravenous) drugs are eligible for inclusion under the “incident to” benefit.

Apparent on its Face: For certain injectable drugs, it will be apparent due to the nature of the condition(s) for which they are administered or the usual course of treatment for those conditions, they are, or are NOT, usually self-administered. For example, an injectable drug used to treat migraine headaches is usually self-administered. On the other hand, an injectable drug, administered at the same time as chemotherapy, used to treat anemia secondary to chemotherapy is not usually self-administered.

By the Patient: the term “by the patient” means Medicare beneficiaries as a collective whole, which includes the patients themselves, and not other individuals who may assist with the administration of the drug. The contractor is not to consider individual beneficiaries who do not have the capacity to SA any drug due to a condition other than the condition for which they are taking the drug in question.

Frequency: to determine frequency, consider how often the drug is administered. For example, if the drug is administered once per month, it is less likely to be SA. If the drug is administered once or more per week, it is likely that the drug is SA.

Usually: for the purposes of applying this exclusion, the term “usually” means more than 50 percent of the time for all Medicare beneficiaries who use the drug, regardless of the indication or route of administration.

Process For Determining List of Excluded Injectable Drugs

During the implementation of this new process for determining coverage of drugs and biologicals, First Coast Service Options (FCSO), Inc.’s current medical review and payment policies will continue to be in effect. Providers will be given a 45-day notice period if a previously covered drug is determined to be non-covered. Also, providers and beneficiaries will have the usual and customary appeal rights for denied coverage. Interested parties who wish to comment on the list should address their comments to First Coast Service Options Medical Affairs, 2020 Technology Parkway, Suite 100, Mechanicsburg, PA 17050-9419 or you may email the comments to MedicalAffairs@guidewellsource.com.

The Process for Determining the List of Excluded Injectable Drugs involves a 10 step process.

Step 1 represents the Apparent on its Face Determination

1. Is it apparent on its face that the drug is self-administrable?
   
   Yes Presumed to be usually self-administered (USA), non-covered.
   
   No Go to Steps 2-6.
   
   Steps 2-6 represent the Presumptive Factors for the Determination of Self-Administration
   
   
2. Is the drug administered orally, topically, or by suppository?
   
   Yes Presumed to be usually self-administered (USA), non-covered.
   
   No Go to question #3.
   
   
3. Is it always administered IV? Absent evidence to the contrary, drugs delivered IV are presumed to not usually be self-administered (NUSA).
   
   Yes Presumed to be NUSA, covered, if other requirements are met.
   
   No Go to question #4.
   
   
4. Is it always administered IM? Absent evidence to the contrary, drugs delivered IM are presumed to not usually be self-administered (NUSA).
   
   Yes Presumed to be NUSA, covered, if other requirements are met.
   
   No Go to question #5.
   
   
5. Is it always administered SQ? Absent evidence to the contrary, drugs delivered SQ are presumed to be self-administered (SA) by the patient.
   
   Yes Presumed to be SA, excluded from coverage.
   
   No Go to steps 6-10.
   
   Steps 6-10 represents the Evidentiary Factors in the Determination Process (These steps are to be used when data exists to support the coverage determination of a drug.)
   
   
6. List the outpatient clinical indication(s) (frequency, chronic/acute conditions as listed in the package insert).
   
   
7. Determine % utilization by clinical indication and route of administration.
   
   Estimate the % SA
   
   (> or < 50%) by indication. Use a variety of sources/factors which include: acute/chronic, setting, clinical parameter, FDA/drug inserts, pharmacy data, hospital data, health plan data, formulary data, etc.
   
   
8. Review claims data for setting, specialty, provider, clinical indication, etc.
   
   
9. Review information from interested parties and prioritize all available levels of evidence and make the final determination.
   
   
10. Was drug determined to be USA by more than 50% of Medicare beneficiaries?

        Yes Non-covered service, 45-day notice period if previously covered, notify via web site.

        No Covered service.

Route of Administration Modifier

The use of the JA and JB modifiers is required for drugs which have one HCPCS Level II (J or Q) code but multiple routes of administration. Drugs that fall under this category will be marked with an asterisk (*) and must be billed with JA modifier for the intravenous infusion of the drug or billed with the JB modifier for subcutaneous form of administration. Absent evidence to the contrary, the Contractor presumes that drugs delivered intravenously are not usually self-administered by the patient. The Contractor will process claims with the JA modifier still applying the policy as stated in the Medicare Benefit Policy Manual, Chapter 15, Section 50.2 that not only must the drug be medically reasonable and necessary, but also that the route of administration is medically reasonable and necessary. Subcutaneously administered drugs listed on the Usually Self-Administered list will be denied as a benefit exclusion. Claims for drugs marked with an asterisk (*) billed without either a JA or JB modifier will also be denied.

The drugs represented by HCPCS codes J0801 and J0802 are administered by IM or SQ, therefore they require the JB modifier to be reported for SQ administration and they should not have any modifier reported for the IM administration.